At a glance
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A Pilot Study of Proton Magnetic Spectroscopy in Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD) Before and After Treatment With Osmotic-controlled Release Oral Delivery System (OROS) Methylphenidate
In Brief
A Phase 4 clinical trial evaluating OROS methylphenidate and No intervention for ADHD. Completed, enrolled 39 participants across 1 site.
Detailed Summary
This will be an open label study using daily does of up to 126mg/day of Concerta in the treatment of children and adolescents, ages 12-17, who meet DSM-IV criteria for ADHD. Specific hypotheses are as follows: Hypothesis 1: Children and adolescents with ADHD will have significantly higher ACC and DLPFC Glutamate/myo-Inositol containing compounds (Glu/Ino) and Glutamate/creatine + phosphocreatine (Glu/Cr) than matched HCS. Hypothesis 2: After six weeks of treatment, OROS methylphenidate will lower ACC and DLPFC Glu/Ino and Glu/Cr levels in children with ADHD who are methylphenidate responders.
Study Details
Timeline
Interventions
Concerta is given in capsule form with a minimum dose of 18 mg/day and a max of 126 mg/day. Subjects take Concerta once per day for 6 weeks.
No intervention